Background:The objective of this
double-blind, placebo-controlled study was to investigate the
efficacy and safety of paroxetine in outpatients with
posttraumatic stress disorder (PTSD).

Method: Male and female outpatients 18 years and
older who met DSM-IV criteria for PTSD and had baseline scores of
50 or greater on the Clinician Administered PTSD Scale (CAPS-2)
were randomly assigned to treatment with paroxetine (20-50
mg/day) or placebo for 12 weeks. The primary efficacy variables
were the change from baseline to the 12-week endpoint in the
CAPS-2 total score and the proportion of responders on the
Clinical Global Impressions-Global Improvement scale (CGI-I).
Additional key outcome measures were the change from baseline in
the reexperiencing, avoidance/numbing, and hyperarousal scores of
the CAPS-2 and in the total scores of the Treatment Outcome PTSD
Scale and the patient-rated Davidson Trauma Scale and Sheehan
Disability Scale (SDS). Depressive symptoms were assessed with
the Montgomery-Asberg Depression Rating Scale. The proportion of
patients achieving response and remission was also determined.

Results: 307 patients constituted the
intent-to-treat population. At week 12, compared with the placebo
group (N = 156), the paroxetine group (N = 151) showed
significantly greater reduction of PTSD symptoms on both of the
primary and all of the secondary outcome measures. Significantly
greater improvement on the CAPS-2 total score was observed for
paroxetine compared with placebo from week 4 (p < .05), and
significantly greater proportions of paroxetine-treated patients
achieved response (p < .001) and remission (p = .008) by week
12. The improvement in PTSD symptoms was similar in male and
female patients. Functional improvement at the study endpoint was
significantly greater (p < .05) in the paroxetine group in all
3 domains of the SDS (work, social life, family life). Treatment
with paroxetine was well tolerated, with the frequency and type
of adverse events recorded for the paroxetine group corresponding
to the known safety profile of this medication.

Conclusion: Paroxetine in doses of 20 to 50 mg
once daily is effective as a treatment for chronic PTSD.
Improvement is obtained for all 3 symptom clusters
(reexperiencing, avoidance/numbing, hyperarousal) and is
associated with significant reduction in disability after 12
weeks of treatment.